A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers

United BioPharma18 enrolled

Overview

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.

This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main Study) and comparative pharmacokinetics study (Sub-study).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasm

Interventions

UB-921BIOLOGICAL

150 mg/vial

HerceptinBIOLOGICAL

440 mg/vial

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Total body weight ≧50 kg (110 lbs) * No clinically relevant abnormalities * To agree on using birth control barrier (eg. male condom) during the entire study period. * Signing the written informed consent form Exclusion Criteria: * Previous exposure to chimeric, humanized or human monoclonal antibody, whether licensed or investigational * A history of drug abuse or heavy drinking. * Blood donation over 250 mL within 90 days prior to the screening * Not in the condition to participate in this study considered by investigator(s)

Locations (1)

Prime site

Taipei, Taiwan

Outcomes

Primary Outcomes

Adverse event incidence

from the baseline to the end of study visit

Time frame: 63 days

Data from ClinicalTrials.gov

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